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EU Roadmap: Finalized Plan For Implementing New Regs Coming Next Month?

A crucial document for industry, the roadmap to the implementation of the EU's new medtech rules, finally seems on the cusp of readiness – four months after the rules entered into force.

Europe Regulation Medical Device

Compliance Corner: Abbott Quality VP Wants You To Talk About These 5 Things At Management Reviews

Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, returns to Compliance Corner with more tips for management reviews. This time, she pinpoints five things that manufacturers should discuss during the meetings.

Quality Control Compliance Quality

Unlocking Social Media's Potential In Health Care

As the use of social media continues to rise and become more ubiquitous, researchers are determining how user data can be used in health-care screening. Medtech Insight explores how social media could be used to predict and manage patient health in the future, including research on its use to improve diabetes management and its potential in mental health assessments.

Digital Health Artificial Intelligence Innovation

Device Week, Sept. 22, 2017 – How FDARA Will Change US FDA Inspections

Discover upcoming tweaks to the agency’s facility inspection approach on this week's Medtech Insight podcast.

Compliance Device Week Policy & Regulation

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Policy & Regulation Explore this Topic

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Germany Votes: But What Will Change For Health Care, Medtech Post-Election?

The German Bundestagswahl – the 2017 general election – looks likely to deliver a fourth straight victory for CDU chief Angela Merkel, Europe's most powerful politician and arguably the world's most powerful national female leader. But she will have to invite coalition partners, as in her previous three regimes, which could spell changes for health and the other ministerial portfolios that touch on medtech.

Germany Policy Medical Device

CMS Seeks Input On New Directions For Innovation Center

The US Centers for Medicare and Medicaid Services has sent out an informal "request for information" for ideas on new directions for the agency's CMS Innovation Center. Administrator Seema Verma says she's seeking new approaches to delivering health care that would promote competition based on quality and outcomes, and provide more transparency to consumers so they can better "shop for services."

Reimbursement Policy United States

UK Begins Brexit Inquiry On Devices, Pharma Supplies

In a busy week for Brexit watchers, the UK government has initiated an inquiry into the effects of future regulatory systems that will potentially impact medical technology and other health-care products in the UK after the country has left the EU.

United Kingdom Brexit

UK MHRA Ensures There Is ‘No Avoiding' Usability Engineering

Changes the UK regulator has made to its guideline on human factors and usability engineering make the document more useful and realistic, and bring it in line with international standards, says a UK-based consultant.

Policy & Regulation Safety

EU Regulatory Update: Where Do We Stand Now – On Shaky Ground?

Most EU regulators are now back in the swing of work after their summer break and the conference season is heating up. What are the key issues likely to top the agenda over the next few months?

Europe Regulation

Easier-To-Clean Duodenoscope Gets US FDA Clearance

The device from Pentax features a disposable distal cap, thus cutting the risk of infection transmission between patients. An earlier Pentax duodenoscope model was the subject of an infection-related safety alert in January.

Safety Approvals

Bayer Halts Essure Sales In EU As US FDA Relies On Study, Patient Warnings

Bayer AG said Sept. 18 it will not renew a CE mark for its Essure permanent contraceptive coils for women in EU countries, effectively halting sales of the product outside the US. The firm says its decision was "unrelated to product safety or efficacy," and driven by its commercial strategy. Meanwhile, US FDA calls for warnings and black box labels for Essure in the US, and says a Sec. 522 post-market study it ordered Bayer to complete "will help us better understand" thousands of complaints about the device.

Europe Gynecology & Urology

US FDA Updates Online Device Export Tracker

The CDRH Export Certification and Tracking System will get a facelift on Sept. 26, with functionality changes to include a mandatory question on a company's most recent FDA inspection.

Medical Device Regulation

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Latest From Quality Control

Device-Makers Can Forego US FDA Pre-Approval Inspections By Joining New 'Critical-To-Quality' PMA Pilot

Nine manufacturers will be selected to play in the agency's voluntary "Premarket Approval Application Critical to Quality" (PMA CtQ) pilot program. Participants will "discuss device design and manufacturing process quality information with FDA early on" to assist "in its review of the PMA manufacturing section and post-approval inspections," the agency says in a notice set to publish in the Sept. 12 Federal Register.

Quality Control Compliance

US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say

The FDA Reauthorization Act, enacted last month, includes provisions that aim to improve FDA's inspection process, including putting a stop to arbitrary audit scheduling by the agency – a practice that can cause a facility inspection to drag on for weeks at a time. FDA has until early 2019 to draft a guidance document that lays out how it will ensure a more uniform inspection process that ensures greater parity between foreign and domestic audits. Steps mandated by the new law include notifying firms in advance of records that will be requested during an inspection and specifying a window of time for investigators to conduct the onsite inspections. But industry experts are of two minds as to whether any substantial changes will result from the new law. Also: FDA device center Director Jeff Shuren weighs in.

Quality Control Compliance

World of Change Coming For Device Manufacturers: Developments In FDA And International Inspections

Device companies have an opportunity to leverage several major reforms and initiatives that are getting off the ground related to global facility inspections. But firms must constructively engage with the new programs to reap benefits, say Akin Gump attorneys and former top US FDA officials Nathan Brown and Howard Sklamberg in this guest column.

Quality Control Compliance

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Sinclair Pharma Bullish About Profitability By Year-End

Encouraged by its solid sales performance in the first half of this year, UK aesthetics company Sinclair Pharma is optimistic it can close out 2017 with a small profit. The firm's H1 revenues were boosted by continued growth in key markets, leading to a 16% top-line growth.

Commercial Companies Medical Device

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Essure Court Cases Move Ahead, Clear Legal Obstacles

Plaintiffs in a lawsuit alleging Bayer’s Essure contraceptive device caused patient injuries filed a revised complaint in California state courts this week. The coordinated proceedings include at least 3,000 patients, though no court date has yet been sent.

Legal Issues Safety

AMRA Brings In New US Sales Leader

Swedish digital health firm AMRA is gearing up to tackle the US market with the appointment of a new head of sales for North America. The company has also added two senior leaders to its Swedish team.

Appointments Digital Health

ABHI 2017: Hopes, Fears And Opportunities On UK Medtech Agenda

Securing market access at a time of an unprecedented budget squeeze, driving forward with medtech and digital innovation plans and maintaining barrier-free access to the EU market: these are the uppermost thoughts on the minds of UK medtech bosses. It's hard, but it's not mission impossible, industry and government leaders said at the ABHI's 2017 UK Market Conference.

United Kingdom Market Intelligence

US FDA Updates Online Device Export Tracker

The CDRH Export Certification and Tracking System will get a facelift on Sept. 26, with functionality changes to include a mandatory question on a company's most recent FDA inspection.

Medical Device Regulation

Medtronic Launches Advanced Chronic Pain Management System

The next-generation Intellis could strengthen Medtronic’s grip on the spinal cord stimulation market, where it already holds a 30.2% share.

Medical Device Neurology

Pacts In Medtech, July/August 2017

Derived from Strategic Transactions, Informa’s premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech column pulls up notable technology alliances, R&D partnerships and commercial collaborations. In this edition, we highlight industry pacts that were sealed in July and August 2017.

Deals Pacts in Medtech

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Leveraging mHealth Data For Product Development: FDA-Supported Action Plan Released

Mobile health devices including wearable consumer products have the potential to collect a lot of medical information that can be useful for product development and tracking. A new action plan from US FDA, industry and other key players outlines ways to harness and use that data to bring better products to market more quickly.

Digital Health Clinical Trials Medical Device

Latest From Research & Development

OUS Approvals Analysis: Medtronic, MicroPort Lead August's Line-Up Of International Approvals

There were 16 CE marks and seven medical device approvals in regions outside of the US and EU in August, according to Medtech Insight's Approvals Tracker. Although 23 approvals in a month is below average for the 2017 OUS tracker, it's more than appeared in August 2016 or 2015, and keeps 2017 on track for 351 approvals from outside the US.

Approvals Innovation

First Anti-Addiction App Approved In The US

Pear Therapeutics' reSET mobile application to treat substance addictions in combination with outpatient therapy programs has been approved by US FDA. The agency approved the software after a multi-site clinical trial showed patients were significantly more successful remaining abstinent after using the app.

Regulation Approvals

US Approvals Analysis: Abbott Leads Another Strong Month For Novel Approvals

Abbott Laboratories accounted for two of five original PMA approvals recorded by US FDA in August. That update and more from Medtech Insight's Approvals Tracker.

Approvals Innovation

UK Industry Targets Best Outcome From Life Science Strategy

The UK medical device industry wasted no time in analyzing the newly-issued Life Sciences Strategy, and found some good elements, but also areas where there is room for improvement.

United Kingdom Market Access

J&J's Ethicon Calls For Game-Changing Holistic Approach To Obesity Care

At this year's 22nd World Congress of the International Federation for the Surgery of Obesity and Metabolic Diseases, Johnson & Johnson subsidiary Ethicon launched a new initiative to significantly alter the way obesity is viewed and to change the patient care pathway for the better.

Metabolic Surgery

ESC 2017: News Flutter With AFib Data

Atrial fibrillation is always a hot topic at cardiology conferences and this year's European Society of Cardiology Congress in Barcelona was no exception. The meeting highlighted data from a spate of key clinical studies providing more insight into this heart condition, including the CASTLE-AF and CAPTAF studies, which further affirmed the benefits of catheter ablation. Outcomes were also reported from REHEARSE-AF and AFFIRM.

Cardiology Innovation